Class II · Moderate risk
Mangiacotti - Ginger Lime Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection.
1,002 FDA drug recalls with this cause, newest first.
These recalls involve bacteria, mold, yeast or other microorganisms actually found in the finished product. This overlaps with sterility issues but is tracked separately because it usually points to a specific breakdown - a water system, an unsealed container, a contaminated raw material - rather than a general process failure. It carries a large share of Class I recalls: an organism such as Burkholderia cepacia or Pseudomonas in an eye drop, nasal spray or oral liquid can cause serious infection.
Class II · Moderate risk
Mangiacotti - Pomegranate Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Clementine Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Ocean Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Lavender Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mangiacotti - Lemon Verbena Hand Sanitizer Spray
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Class II · Moderate risk
Dollar General Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
Dr. Sheffield Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
Phenylephrine Nasal 1% Spray
Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
Class II · Moderate risk
Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Class II · Moderate risk
Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Class II · Moderate risk
Dexpanthenol 250mg/ml PF
The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Class II · Moderate risk
Glutathione 100 mg/mL Injectable
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Class II · Moderate risk
REEVA (triclosan)
Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
Class II · Moderate risk
Ranitidine Hydrochloride Tablets
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Class III · Low risk
Alcohol Free Antiseptic
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Class II · Moderate risk
Dicopanol FusePaq Kit for Oral Suspension
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Class II · Moderate risk
"Well at Wallgreens" Regular Strength Antacid Liquid
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Class II · Moderate risk
All Compounded Products
Lack of Assurance of Sterility; potential for mold contamination
Class I · High risk
Magnesium Sulfate 2 grams in Dextrose 5% for Injection
Non-Sterility; mold contamination
Class II · Moderate risk
Amoxicillin for Oral Suspension
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
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